Table 1.
Summary of HIV-related baseline characteristics and SARS-COV-2 immune responses after COVID-19 mRNA-based vaccination trials in PLWH on diverse ARTs.
| Author Reference / Country | Patients [n] | Median age [years](range) | Patient received vaccine [n] | Patients on ART [n] | Antiretroviral drugs regimen | Baseline characteristics of PLWH | Co-morbidities [n] | Cut off [Unit] | Anti-S IgG titres after vaccination | Anti-RBD IgG titres after vaccination | nAbs response [n]/ total [n] | IFN-γ (SFU/million PBMCs) [median] | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| PLWH | Controls | PLWH | Controls | BNT162b2 | mRNA-1273 | HIV viral load (copies/mL) [n] | CD4+ T cell count (cells/μL) [n] | PLWH | Controls | CD4+ T cell count (cells/μL) | All PLWH | Controls | PLWH | Controls | PLWH | Controls | |||||||||||||
| Detectable | Undetectable | <200 | 200-350 | 350-499 | >500 | Anti-S IgG | Anti-RBD IgG | <200 | 200-350 | 350-499 | >500 | ||||||||||||||||||
| Woldemeskel et al. [14] / U.S.A | 12 | 17 | 52 (25; 59) | 41 (24-59) | 29 | 0 | 12 | Integrase Inhibitor, NNRTI, Protease Inhibitor, NRTI | 3 | 9 | 0 | 0 | 0 | 12 | n.r. | n.d. | n.d. | 8.84 | 9.49 | n.d. | n.d. | n.d. | n.d. | n.d. | n.d. | 12/12 | 0 | 230 | 190 |
| Levy et al. [17] / Israel | 143 | 261 | 49,8 ± 11,6 (mean ± SD) | 55,8 ± 14.3 (mean ± SD) | 404 | 0 | 143 | Integrase inhibitor- based therapy (94.4%) | 7 | 136 | 3 | 0 | 0 | 140 | 16 (*) | n.d. | n.d. | n.d. | n.d. | n.d. | n.d. | n.d. | n.d. | GMT (95% CI): 5.2 (4.8-5.5) | GMT (95% CI): 6 .1 (5.8-6.4) | 131/135 | 197/201 | n.d. | n.d. |
| Noe et al. [13] / Germany | 665 | 231 | 53 (43; 59) | n.a. | 582 | 8 | n.r | n.r. | 43 | 622 | 14 | 651 | n.r. | IgG> 34 BAU/mL | n.d. | 1400 (IQR 664; 2130) | n.d. | n.d. | n.d. | n.d. | n.d. | n.d. | n.d. | n.d. | n.d. | n.d. | n.r. | ||
| Tuan et al. [16] / U.S.A | 39 | 0 | >55 | n.a. | 39 | 0 | 38 | Integrase Inhibitor, NNRTI, Protease Inhibitor | 7 | 32 | n.r. | n.r. | n.r. | 28 | 46 (**) | n.d. | n.d. | n.r. ; 38/39 showed positive IgG response | n.d. | n.d. | n.d. | n.d. | n.d. | n.d. | n.d. | n.d. | n.d. | n.d. | n.d. |
| Nault et al. [21] / Canada | 106 (***) | 20 | 43 (21; 65) | 47 (21;59) | Controls: 20 | PLWH: 106 | 106 | n.r. | n.r. | n.r. | 6 | 18 | 82 | n.r. | n.d. | 2.56 RLU | n.d. | n.d. | Mean 4.75 RLU | Mean 50.71 RLU | n.r. | n.r. | 100/106 | 19/20 | n.d. | n.d. | |||
| Ruddy et al. [20] / U.S.A | 14 | 0 | 62 (56; 70) | n.a. | 5 | 9 | 14 | n.r. | 1 | 13 | 2 | 1 | 3 | 8 | n.r. | n.d. | IgG > 0.8 U/mL | n.d. | n.d. | n.d. | n.d. | n.d. | n.d. | >250 U/mL (all patients except for one); >239 U/mL one patient with CD4+ T cell count <200 | n.d. | n.d. | n.d. | n.d. | n.d. |
| Jedicke et al. [7]/ Germany | 52 (****) | 41 | 60,2 (32-85) [mean (range)] | 44 (23-61) [mean (range)] | 93 | 0 | 52 | n.r. | 1 | 51 | n.r. | n.r. | n.r. | 52 | n.r. | n.d. | n.d. | 246.2 RU/mL (IQR 218.7) | 502.5 RU/mL (IQR 118.8) | n.d. | n.d. | n.d. | n.d. | n.d. | n.d. | 48/52 | n.d. | n.d. | n.d. |
| Lombardi et al. [18]/ Italy | 71 | 10 | 47 ± 8 (mean ± SD) | 58 ± 8 (mean ± SD) | 0 | 81 | 71 | Integrase Inhibitor, NNRTI, Protease Inhibitor | 5 | 66 | 0 | 6 | 7 | 58 | 7 (*****) | n.d. | n.d. | 2437 U/mL IQR (1485-4526) (§) | 1077 U/mL IQR(702-7551) | n.d. | n.d. | n.d. | n.d. | n.d. | n.d. | 71/71 | 10/10 | n.d. | n.d. |
| Milano et al. [15]/ Italy | 697 (******) | 0 | 53 (19-79) | n.a. | 697 | 0 | 696 | n.r. | 65 | 632 | 14 | 683 | 345 (******) | n.d. | IgG > 50 AU/mL | n.d. | n.d. | n.r. | n.r. | n.r. | n.r. | 7582 (44.7->200.000); (99.8%) | n.d. | n.d. | n.d. | n.d. | n.d. | ||
| Oyaert et al. [10]/ Italy | T2: 27; T3: 25 (*******) | 51 | 47 (30-66) [mean (range)] | 37 (17-63) | T2: 27; T3: 25 | 0 | n.r. | n.r. | n.r. | n.r. | n.a. | 25 | n.a. | n.a. | n.r. | IgG > 33.8 BAU/mL | n.d. | T2: Median (BAU/mL, min-max) 3140 (200-22400); T3: Median (BAU/mL, min-max) 788 (75.4-8860) | T2: Median (BAU/mL, min-max) 3455 (674-25400); T3: Median (BAU/mL, min-max) 1320 (104-8330) | n.r. | n.r. | n.r. | n.r. | n.d. | n.d. | n.d. | n.d. | T3: 68% patients responded (17/25) | T3: 88.2% patients responded (45/51) |
Abbreviations: PLWH, people living with Human Immunodeficiency Virus (HIV); ART, antiretroviral therapy; n, numbers; IQR, interquartile range; SD: standard deviation; GMT, geometric mean titres; IC, confidence interval; IU: international units; RLU, relative luminescence units; BAU, binding antibody unit; RLU, relative luminiscence units; SFU, spot forming units; PBMC, peripheral blood mononuclear cell; NNRTI, nonnucleotide/nonnucleoside reverse transcriptase inhibitor, nAbs, neutralizing antibodies; anti-RBD: anti-receptor binding domain protein; anti-S, anti-Spike; IFN-γ, interferon-γ; Ag, antigen; n.r, non-reported; n.d, not done; n.a., not applicable
(*) Co-morbidities included hypertension, diabetes mellitus, dyslipidaemia, ischaemic heart disease, chronic obstructive pulmonary disease, kidney disease and liver disease.
(**) Co-morbidities included cancer or other immunosuppressive conditions, diabetes, cardiovascular disease, lung disease, advanced liver disease, chronic kidney disease.
(***) While 121 participants were recruited, only 106 were analized due to that 11 had anti-COVID19 antibodies at baseline.
(*****) Co-morbidities included dyslipidemia, hypertension, Hepatitis B, Hepatitis C, diabetes, renal and cardiovascular diseases and history of neoplasms.
(****) While 88 patients were recruited in the study, only 52 patients received the two doses of the vaccine.
(******) 697 patients were analyzed at prime time-point; 577 analyzed at the boost time-point and 491 at the post-second boost time-point. Co-morbidities included dyslipidaemia, hypertension, diabetes, cardiac and/or vascular disease and chronic obstructive pulmonary disease (COBD).
(*) Co-morbidities included hypertension, diabetes mellitus, dyslipidaemia, ischaemic heart disease, chronic obstructive pulmonary disease, kidney disease and liver disease.
(**) Co-morbidities included cancer or other immunosuppressive conditions, diabetes, cardiovascular disease, lung disease, advanced liver disease, chronic kidney disease.
(*******) Analysis of the response was analyzed after 10 to 14 days (T2) and 3 months (T3) after administration of the second vaccine dose.
(*******) Analysis of the response was analyzed after 10 to 14 days (T2) and 3 months (T3) after administration of the second vaccine dose.